Transforming Cancer Research through Cell Authentication

Transcription

1 PROGRAM BIO POLICY SUMMIT Transforming Cancer Research through Cell Authentication November 13, 2014 The Knight Conference Center at The Newseum Washington, D.C. SPONSORS BioResearch

2 WELCOME Dear Colleagues, Thank you for joining the Global Biological Standards Institute (GBSI) at our inaugural BioPolicy Summit: Transforming Cancer Research through Cell Authentication. As the first in a series of strategic explorations of critical topics in life sciences, this Summit will focus on the transformative impact cell authentication can have in improving cancer study replication. We are honored to have you with us today. By bringing together leaders from many areas of the life science community, including academia, government, industry, patient advocacy, journal publishing, and funding, we have a unique opportunity to listen to and learn from a variety of stakeholders to better understand the important role each of us plays. Together, through insightful and productive discussions, we will identify best practices and policies to accelerate the discovery of life-saving therapies and cures particularly as they relate to establishing validity and improved translation of biomedical research. By attending this Summit, you are demonstrating your commitment to understanding and addressing the critical role cell authentication plays in ensuring research reproducibility. We look forward to your valuable contributions at the Summit and in future collaborations. The successful adoption of best practices and standards is challenging, as evidenced by the experiences of a myriad of other industries. But, it is critical for the life science community to move this agenda forward. On behalf of GBSI, I thank you again for joining us and look forward to a productive and informative Summit. Best regards, Leonard P. Freedman, PhD President 2 Global Biological Standards Institute #BioPolicy14

3 AGENDA BioPolicy Summit: Transforming Cancer Research through Cell Authentication AGENDA 11:30 a.m. Registration, Networking & Buffet Lunch 12:00 p.m. Welcome & Introductions Leonard P. Freedman, PhD, President, GBSI 12:10 p.m. Keynote Presentation Keith Yamamoto, PhD, Vice Chancellor for Research, University of California, San Francisco, and Executive Vice Dean, UCSF School of Medicine 12:35 p.m. Panel Session Moderated by Richard Harris, Science Correspondent, National Public Radio News 1:30 p.m. Q&A Panel Members Véronique Kiermer, PhD Executive Editor, Nature Publishing Group Jon R. Lorsch, PhD Director, National Institute of General Medical Sciences, National Institutes of Health Richard M. Neve, PhD Scientist, Discovery Oncology, Genentech Howard R. Soule, PhD Chief Science Officer, Prostate Cancer Foundation and Senior Fellow, Milken Institute 1:55 p.m. Closing Remarks Transforming Cancer Research through Cell Authentication 3

4 CASE FOR SUPPORT Why Authenticate Cells? Case for Support Advances in life science research, including the development of life-saving therapies and cures, build upon the reproducibility and translation of previously published data and findings. Yet irreproducibility in basic and preclinical biological research is a pervasive, expensive, and increasingly well-recognized problem. In simplest terms, reproducibility means that an experiment should be able to be reproduced in an independent lab with results that broadly support the conclusions of the original scientist. Irreproducible life science research has resulted in multiple failed clinical trials involving innumerable patients and contributes to both delays and costs of therapeutic drug development. Most irreproducibility results from cumulative errors or flaws in the following areas of the research process: reference materials, study design, laboratory protocols, and data analysis and reporting. For example, irreproducibility can occur when two laboratories perform the same experiment but use different reagents. Such reference material errors, although relatively inexpensive to address early in the research process, often result in significant, albeit rarely quantified, hard dollar costs. An all too common contributor to a lack of reproducible life science research is the widespread use of misidentified or contaminated cell lines isolated from various human cancers. Cell lines have been used for decades in multiple areas of biomedical research. At the same time, the chronic problem of cell line misidentification, particularly cross-contamination by HeLa and its variants, spans decades. One widely cited survey examined the prevalence of contaminated cancer cell line usage during a period of more than 20 years and reported contamination rates ranging from a low of 15 percent to a high of 36 percent. Despite the availability of the short-tandem repeat (STR) analysis as an accepted standard to authenticate cell lines, and its relatively low cost (approximately $200 per assay), it is unknown how many laboratories authenticate their cell lines and how often. The poster child for misidentified cell lines is MDA-MB-435. More than 1,000 articles have been published on this cell line as a triple-negative, metastatic breast cancer cell line that grows well in culture. It was later reported to have an identical STR profile to that of the melanoma cell line, M14. Since then, a controversy has raged as to the provenance of either cell line. Use of MDA-MB-435 has wasted a conservative estimate of millions of dollars of public and private research funds; moreover, all data and results generated using these lines are not reliable. However, even after its true identity was revealed in 2004, researchers continued to include the MDA-MB-435 cell line model in grant applications for breast cancer research. This demonstrates the need to raise awareness of the importance of using authentic, contaminant-free cell lines through use of STR profiling or other innovative technologies like single-nucleotide polymorphism (SNP) profiling. 4 Global Biological Standards Institute #BioPolicy14

5 CASE FOR SUPPORT This is not a new problem, and although several consistent solutions have been offered (and in some limited venues adopted) over the years, it has proven surprisingly difficult to eradicate. A systemic culture change from top-to-bottom from researchers to funders to publishers is needed. As has happened in many other industries, from technology to health care to computer systems, the life sciences community must embrace the expanded development and use of best practices and standards to improve the credibility, reproducibility, and translatability of preclinical research using cancer cell lines. GBSI s Cancer Cell Authentication and Standards Task Force was established to explore this issue and share insights from the members areas of expertise. The Task Force has recently submitted a paper to a peer-reviewed publication on the topic of irreproducibility and the need to change the policies and culture of cancer cell authentication. The Task Force recommendations include: 1. Change the Culture: Practices of the research community should embrace the importance of cell authentication. 2. Use Standards and Best Practices: Documented authentic, contaminant-free cell lines should be used in research. 3. Establish Dedicated Funding: Research grants should include the costs to address cell authentication. 4. Authenticate to Publish: Journals should require documentation of cell authentication. 5. Commit to Train: Graduate students and postdoctoral fellows should receive more information on the importance of cell authentication. 6. Invest in New Technologies: There should be greater investment in the development of novel tools for cell authentication. GBSI Cancer Cell Authentication and Standards Task Force Members Chair Leonard P. Freedman, PhD, President, GBSI Stephen P. Ethier, PhD, Medical University of South Carolina, Charleston, SC Richard M. Neve, PhD, Scientist, Discovery Oncology, Genentech, South San Francisco, CA Yvonne A. Reid, PhD, Manager, Scientist, Cell Culture Contracts, ATCC, Manassas, VA Howard R. Soule, PhD, Chief Science Officer, Prostate Cancer Foundation and Senior Fellow, Milken Institute, Santa Monica, CA Observer James F. Deatherage, PhD, Program Director, Cell Biology Branch, National Institutes of Health/National Institute of General Medical Sciences, Bethesda, MD Transforming Cancer Research through Cell Authentication 5

6 SPEAKERS Keith Yamamoto, PhD Vice Chancellor for Research, University of California, San Francisco, and Executive Vice Dean, UCSF School of Medicine KEYNOTE SPEAKER Keith Yamamoto is vice chancellor for research, executive vice dean of the School of Medicine, and professor of cellular and molecular pharmacology at the University of California, San Francisco. His research is focused on signaling and transcriptional regulation by nuclear receptors, which mediate the actions of several classes of essential hormones and cellular signals. Dr. Yamamoto has led or served on numerous national committees focused on public and scientific policy, public understanding and support of biological research, and science education. He has also chaired or served on many committees that oversee the process of peer review and the policies that govern it at the National Institutes of Health. Dr. Yamamoto is a member of the National Academy of Sciences, the Institute of Medicine, the American Academy of Arts and Sciences, and the American Academy of Microbiology, and is a fellow of the American Association for the Advancement of Science. 6 Global Biological Standards Institute #BioPolicy14

7 SPEAKERS Richard Harris Science Correspondent, National Public Radio News MODERATOR Award-winning journalist Richard Harris has reported on a wide range of topics in science, medicine and the environment since he joined National Public Radio in In early 2014, his focus shifted from an emphasis on climate change and the environment to biomedical research. Over the course of his career, Harris has been the recipient of many prestigious awards. Those include the American Geophysical Union s 2013 Presidential Citation for Science and Society. He shared the 2009 National Academy of Sciences Communication Award and was a finalist again in In 2002, Harris was elected an honorary member of Sigma Xi, the scientific research society. Harris shared a 1995 Peabody Award for investigative reporting on NPR about the tobacco industry. Since 1988, the American Association for the Advancement of Science has honored Harris three times with its science journalism award. Harris is co-founder of the Washington, D.C., Area Science Writers Association, and is past president of the National Association of Science Writers. He serves on the board of the Council for the Advancement of Science Writing. Transforming Cancer Research through Cell Authentication 7

8 SPEAKERS Véronique Kiermer, PhD Executive Editor, Nature Publishing Group PANEL MEMBER Véronique Kiermer, PhD, is executive editor and head of Researchers Services for Nature Publishing Group (NPG). She obtained her PhD in molecular biology from the Université Libre de Bruxelles, Belgium. Her postdoctoral work was in the laboratory of Dr. Eric Verdin at the Gladstone Institute of Virology and Immunology, University of California, San Francisco, studying the transcriptional regulation of HIV. She then worked on gene therapy projects at the biotechnology company Cell Genesys before moving to Nature Publishing Group in At NPG, she was the founding chief editor of Nature Methods and subsequently took on publishing responsibility for the title and other online products. In October 2010, she became executive editor, overseeing editorial policies and editorial quality assurance for Nature and the Nature journals. She also heads NPG s Researchers Services, developing initiatives to benefit scientists in their roles as researchers, authors, and referees. 8 Global Biological Standards Institute #BioPolicy14

9 SPEAKERS Jon R. Lorsch, PhD Director, National Institute of General Medical Sciences, National Institutes of Health PANEL MEMBER Jon Lorsch, PhD, became the director of the National Institute of General Medical Sciences (NIGMS) in August In this position, he oversees the Institute s $2.359 billion budget, which funds basic research in the areas of cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, biomedical technology, bioinformatics, and computational biology as well as selected areas of clinical research. NIGMS supports more than 4,500 research grants about 10.5 percent of those funded by the National Institutes of Health (NIH) as a whole as well as a substantial amount of research training and programs designed to increase the diversity of the biomedical research workforce. Dr. Lorsch s early efforts at NIGMS have included initiating the development of a new strategic plan for the Institute and analyzing its grant portfolio. He is committed to supporting investigator-initiated research and to ensuring that the Institute is investing the taxpayers money in the most effective and efficient way possible. Dr. Lorsch came to NIGMS from the Johns Hopkins University School of Medicine, where he was a professor in the Department of Biophysics and Biophysical Chemistry. His research on RNA biology, which he continues at a lab housed in another part of NIH, was supported by grants from NIGMS, other NIH institutes, and additional funding organizations. Transforming Cancer Research through Cell Authentication 9

10 SPEAKERS Richard M. Neve, PhD Scientist, Discovery Oncology, Genentech PANEL MEMBER Richard Neve, PhD, has 20 years of experience in the life sciences spanning academia and industry. After earning a PhD studying the ERBB2 oncogene at the Friedrich Miescher Institute for Biomedical Research (Basel, Switzerland), he was a postdoctoral fellow at the University of California, San Francisco and Lawrence Berkeley National Laboratories where he utilized genomics to identify therapeutic targets in breast cancer. Dr. Neve is currently a scientist in Discovery Oncology, Genentech where in addition to his target discovery group, he built a centralized cell bank to deliver quality assured cell lines with the research organization. 10 Global Biological Standards Institute #BioPolicy14

11 SPEAKERS Howard R. Soule, PhD Chief Science Officer, Prostate Cancer Foundation and Senior Fellow, Milken Institute PANEL MEMBER Howard Soule, PhD, coordinates global academic, government and biopharmaceutical sector research activity and is responsible for the implementation of Prostate Cancer Foundation (PCF) s global research strategies. From 1997 to 2004, he was executive vice president and chief science officer of PCF. He is also a member of the Department of Defense Prostate Cancer Research Program Integration Panel. Most recently, he was managing director of Knowledge Universe Health and Wellness Group, a private investment firm focused on companies in the general areas of disease prevention and treatment. Dr. Soule has been with the Foundation for 11 years. Prior to joining PCF in 1997, Dr. Soule was a senior R&D executive for nine years at Corvas International, Inc., a public biotechnology company. He was responsible for the discovery and development of innovative products for the treatment of life-threatening cardiovascular diseases. Dr. Soule has considerable experience in medical diagnostic and device industries as well. Dr. Soule received a PhD from Baylor College of Medicine in Virology and Epidemiology and was a postdoctoral fellow in Immunology and Vascular Biology at the Scripps Research Institute. Transforming Cancer Research through Cell Authentication 11

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